FEATURED EDITORIAL
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
- June 2026 — CDMO Opportunities And Threats Report
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
- Reshoring Pressure Meets Manufacturing Reality
- CDMO Live Europe 2026: Partnerships For An Uncertain World
- Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
- Are Drug Sponsors Reshaping Today's CDMOs?
GUEST COLUMNISTS
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The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
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Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
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Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
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CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
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Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
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Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
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Let's Stop Treating Allogeneic Cell Therapy As One Thing
Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.
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Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.
PHARMA OUTSOURCING WHITE PAPERS
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Don't Let Formulation Failures Derail Drug Development
In the face of increasing molecular complexity, early developability assessment with a skilled CDMO can reduce pharmaceutical development costs, prevent clinical delays, and improve commercial success.
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Applications Of Liquid-Filled Capsules For Challenging APIs In Pharmaceutical Manufacturing
Discover the benefits of liquid-filled capsules for efficient, scalable, and patient-friendly drug manufacturing, and how they can enhance bioavailability and simplify complex formulations.
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Accelerating Drug Development: Solid State Chemistry And Strategic Outsourcing
Discover how phase‑appropriate solid‑state chemistry and strategic outsourcing reduce risk, speed development timelines, and enable confident solid‑form selection for complex small‑molecule programs.
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A Scalable Platform To Revolutionize Gene Therapy Manufacturing
Discover how our innovative rAAV production platform can revolutionize your gene therapy pipeline with unparalleled yield, quality, and scalability.
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AAV-Based Gene Editing For Huntington's Disease
LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.
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The Key To Viral Vector Success
Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
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ON-DEMAND WEBINARS
- Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies
- Enhancing AAV Manufacturing Yield Via Mini-Helper Plasmid
- When High-Stakes ADC Decisions Can't Wait for More Material or Better Data
- Beyond Outsourcing: Turning Your CDMO Into A Value-Creation Engine
- July Kincell Bio Webinar